The Food and Drug Administration (FDA) has given the go-ahead to Bayer’s updated post-market surveillance study plan for its non-surgical permanent birth control device Essure. The controversial contraceptive has been linked to tens of thousands of adverse events including allergic reactions, autoimmune reactions, unintended pregnancies, miscarriages and fetal deaths, and four cases of adult death. The device can also migrate from its intended position in the fallopian tubes and damage neighboring tissue and organs.
Essure, made by Bayer and approved for marketing in the U.S. in 2002, consists of two nickel alloy coils that are inserted into the fallopian tubes where they build up scar tissue, creating a permanent barrier between the sperm and the egg. A growing number of adverse event complaints prompted the formation of the Facebook group, Essure Problems, and the advocacy group E-Sisters, who lobbied the FDA to ban the device.
As a result, the FDA conducted a safety review of Essure and in February fell short of banning the device. Instead, the agency placed a black box warning on the label of Essure and ordered Bayer to conduct post-market studies to gather “real world” safety data.
Bayer’s open-label, non-randomized, prospective observational study will observe two groups of 1,400 women between the ages of 21 and 45 who have not been pregnant within the previous six weeks and who chose either Essure or laparoscopic tubal ligation. The final report on the study is expected in 2018. However, through March 2017, a six-month report will be released and in early September 2017, a one-year report will be released.
The study’s endpoints include chronic abdominal or pelvic pain, abnormal bleeding, allergic reactions, and the surgical removal of Essure. Secondary safety endpoints include additional data on bloodwork, pathology, histology and metallurgic testing. The device’s effectiveness at preventing pregnancy will also be gauged.